Acular 0.5% Ophth Solution 10ml
It is used to treat eye irritation due to allergies.It is used to treat pain and other irritation after certain types of eye surgery.
Drug Class
Ophthalmic Nonsteroidal Anti-inflammatory Drug (NSAID)
Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
Pregnancy Category
Category C (first/second trimester), Category D (third trimester)
FDA Approved
Jan 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketorolac eye drops are used to reduce pain, swelling, and redness in the eye, often after eye surgery or for certain types of eye allergies. It works by blocking natural substances in your body that cause inflammation.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal use:
Apply this medication only to the eye.
Wash your hands thoroughly before and after using the medication.
Avoid wearing contact lenses while using this medication.
To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to the eye, eyelid, or surrounding skin.
Administration Technique
1. Tilt your head back and gently drop the medication into the eye.
2. If you are using more than one medication in the same eye, allow at least a 5-minute interval between each application.
3. If you have undergone surgery on both eyes and are using this medication, your doctor may prescribe two separate bottles - one for each eye. Ensure you do not mix up the bottles.
Storage and Disposal
Store the medication at room temperature, protected from light.
Keep all medications in a secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at once or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal use:
Apply this medication only to the eye.
Wash your hands thoroughly before and after using the medication.
Avoid wearing contact lenses while using this medication.
To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to the eye, eyelid, or surrounding skin.
Administration Technique
1. Tilt your head back and gently drop the medication into the eye.
2. If you are using more than one medication in the same eye, allow at least a 5-minute interval between each application.
3. If you have undergone surgery on both eyes and are using this medication, your doctor may prescribe two separate bottles - one for each eye. Ensure you do not mix up the bottles.
Storage and Disposal
Store the medication at room temperature, protected from light.
Keep all medications in a secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at once or take extra doses.
Lifestyle & Tips
- Wash hands thoroughly before and after administering eye drops.
- Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
- Tilt head back, pull down the lower eyelid to form a pouch, and instill one drop into the pouch. Close eye gently for a few minutes.
- If using other eye drops, wait at least 5 minutes between applications.
- Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
- Do not wear contact lenses if you have active eye inflammation or infection.
- Store at room temperature, away from light and moisture.
- Do not use if the solution changes color or becomes cloudy.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop to the affected eye(s) 4 times daily
Condition-Specific Dosing:
Post-operative inflammation following cataract extraction:
1 drop to the affected eye(s) 4 times daily, starting 24 hours after surgery and continuing for up to 2 weeks.
Seasonal allergic conjunctivitis:
1 drop to the affected eye(s) 4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 3 years of age. For children 3 years and older, dosing may be similar to adults for specific indications, but consult prescribing information.
Adolescent:
1 drop to the affected eye(s) 4 times daily (similar to adult dosing for approved indications).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations for ophthalmic use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory activity by inhibiting prostaglandin biosynthesis. It achieves this by reversibly inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, which are responsible for converting arachidonic acid into prostaglandins. Prostaglandins are mediators of inflammation, pain, and fever. In the eye, this inhibition reduces inflammation and pain associated with ocular conditions.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<1%) following ophthalmic administration.
Tmax:
Not applicable for systemic Tmax due to minimal absorption; local ocular concentrations peak rapidly.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not applicable for systemic Vd due to minimal absorption; primarily distributed locally within ocular tissues.
ProteinBinding:
Not applicable for systemic protein binding due to minimal absorption; systemic ketorolac is highly protein bound (>99%).
CnssPenetration:
No (minimal systemic absorption, not intended for CNS effect).
Elimination:
HalfLife:
Not applicable for systemic half-life due to minimal absorption; systemic ketorolac has a half-life of approximately 5-6 hours.
Clearance:
Not applicable for systemic clearance due to minimal absorption.
ExcretionRoute:
Primarily renal for systemically absorbed drug.
Unchanged:
Not applicable for systemic unchanged excretion due to minimal absorption.
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Within 1-2 days of regular dosing for maximal anti-inflammatory effect.
DurationOfAction:
Approximately 6-8 hours per dose (requiring QID dosing).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
- Changes in eyesight, eye pain, or severe eye irritation.
- Bleeding in the eye.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience:
- Eye irritation.
- Blurred eyesight.
- Headache.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
- Changes in eyesight, eye pain, or severe eye irritation.
- Bleeding in the eye.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience:
- Eye irritation.
- Blurred eyesight.
- Headache.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe eye pain or discomfort
- Worsening redness or swelling
- Vision changes (e.g., decreased vision, blurred vision)
- Signs of eye infection (e.g., pus, excessive discharge)
- Persistent itching or irritation
- Signs of corneal damage (e.g., foreign body sensation, excessive tearing, sensitivity to light)
- Allergic reaction (e.g., rash, itching/swelling of face/tongue/throat, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication in conjunction with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication in conjunction with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a current eye infection, have suffered an eye injury, or are scheduled to undergo eye surgery, be sure to notify your doctor. Additionally, if you experience an eye wound or irritation that does not heal, consult with your doctor promptly. When taking this medication, exercise caution when driving or performing tasks that require clear vision. Do not exceed the prescribed duration of use, as directed by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best decision for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If excessive drops are instilled, flush the eye with lukewarm water. If systemic overdose is suspected (highly unlikely with ophthalmic use), contact a poison control center (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- Other topical NSAIDs (increased risk of corneal complications)
- Topical corticosteroids (may mask signs of infection, potential for additive corneal effects)
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp, intraocular pressure)
Rationale: To establish baseline ocular health and assess the condition requiring treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Ocular examination (visual acuity, slit lamp)
Frequency: As clinically indicated, especially if symptoms worsen or new symptoms appear.
Target: Improvement in inflammation/pain, stable or improved visual acuity.
Action Threshold: Worsening symptoms, signs of infection, corneal complications (e.g., thinning, melting), or persistent irritation.
Intraocular pressure (IOP)
Frequency: If used concurrently with topical corticosteroids or in patients at risk for elevated IOP.
Target: Normal range for the patient.
Action Threshold: Significant increase in IOP.
Symptom Monitoring
- Eye pain
- Redness
- Swelling
- Itching
- Blurred vision
- Discharge
- Sensitivity to light
- Signs of corneal irritation or damage (e.g., foreign body sensation, excessive tearing)
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided, especially in the third trimester, due to potential for premature closure of the fetal ductus arteriosus and inhibition of uterine contractions. While systemic absorption from ophthalmic use is minimal, caution is advised. Category C for first/second trimester, Category D for third trimester.
Trimester-Specific Risks:
First Trimester:
Category C - Animal studies have shown adverse effects, but human data is lacking. Use only if potential benefit justifies potential risk.
Second Trimester:
Category C - Animal studies have shown adverse effects, but human data is lacking. Use only if potential benefit justifies potential risk.
Third Trimester:
Category D - Known human fetal risk (premature closure of ductus arteriosus, persistent pulmonary hypertension, renal dysfunction, oligohydramnios, inhibition of labor). Contraindicated.
Lactation
Ketorolac is excreted in human milk following systemic administration. While systemic absorption from ophthalmic use is minimal, caution is advised. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother. L3 (Moderate risk) due to potential for systemic absorption and excretion into milk.
Infant Risk:
Low risk for ophthalmic use due to minimal systemic absorption, but theoretical risk of adverse effects on infant (e.g., platelet dysfunction, renal effects) if significant absorption occurs.
Pediatric Use
Safety and effectiveness in pediatric patients younger than 3 years of age have not been established. Use in older pediatric patients should be based on specific indications and careful consideration of risks vs. benefits.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dosage adjustment is typically required for ophthalmic use in geriatric patients.
Clinical Information
Clinical Pearls
- Ketorolac ophthalmic is effective for post-operative inflammation and seasonal allergic conjunctivitis, but not for bacterial conjunctivitis.
- Patients should be advised about the potential for transient stinging or burning upon instillation.
- Prolonged use of topical NSAIDs, especially in patients with compromised corneas (e.g., diabetes, rheumatoid arthritis, previous eye surgery), may lead to corneal adverse events including thinning, erosion, ulceration, or perforation. Monitor these patients closely.
- Avoid concomitant use with other topical NSAIDs to minimize the risk of corneal complications.
- If signs of infection develop, discontinue ketorolac and initiate appropriate anti-infective therapy.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., bromfenac, diclofenac, nepafenac, flurbiprofen)
- Topical corticosteroids (e.g., prednisolone acetate, dexamethasone) for inflammation (with different side effect profiles)
- Mast cell stabilizers (e.g., cromolyn, lodoxamide) for allergic conjunctivitis
- Antihistamine/mast cell stabilizer combinations (e.g., olopatadine, azelastine) for allergic conjunctivitis
Cost & Coverage
Average Cost:
$50 - $150 per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1-3 (depending on generic vs. brand and specific plan formulary)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.